TILT Biotherapeutics presented Phase I clinical data at ESMO 2024, showcasing the potential of fully intravenous TILT-123 monotherapy in advanced solid cancers.

Biotron's Phase 2 clinical trial of BIT225 for COVID-19 met its primary safety and tolerability endpoint, showing adverse events consistent with previous trials.

The Drugs Controller General of India (DCGI) has suspended Entod Pharmaceuticals' PresVu eye drops approval due to concerns of overselling its benefits.

F2G has raised $100 million to fund late-stage testing of olorofim, an antifungal drug intended to treat invasive aspergillosis, after initial FDA rejection.

The ARANOTE trial demonstrated that darolutamide plus androgen deprivation therapy (ADT) significantly improves radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The Israeli Ministry of Health has approved tislelizumab (Tevimbra) as monotherapy for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy.

MannKind's ICoN-1 Phase 3 trial of Clofazimine Inhalation Suspension for NTM lung disease has been cleared by Japan's PMDA, expanding the trial globally.

A recent study reveals that the Research to Accelerate Cures and Equity (RACE) Act has led to a significant increase in post-approval pediatric testing requirements for cancer drugs.

The Montreal Children's Hospital Foundation received a $1 million donation to double pediatric cancer clinical trials by 2027, offering hope for children with rare and aggressive cancers.

The European Medicines Agency (EMA) has finalized a reflection paper addressing the use of single-arm trials for establishing drug efficacy, providing guidance for pharmaceutical companies.

Cybin is set to initiate a Phase 3 study of CYB003 for Major Depressive Disorder (MDD) following a productive meeting with the FDA.

The European Medicines Agency reaffirmed its rejection of Apellis' Syfovre for treating geographic atrophy, despite the company's efforts to re-evaluate the supporting evidence.

Peptide-drug conjugates (PDCs) are emerging as a novel class of cancer therapeutics, offering potential advantages over antibody-drug conjugates (ADCs) due to their smaller size and rapid internalization.

Senseonics and Ascensia Diabetes Care secured FDA clearance for Eversense 365, a next-generation continuous glucose monitoring (CGM) system, for adults with type 1 and type 2 diabetes.

A study published in _Annals of Neurology_ highlights the effectiveness of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) for drug-resistant epilepsy caused by periventricular nodular heterotopia (PNVH).

A Phase 2 trial of tulisokibart, an anti-TL1A monoclonal antibody, demonstrated superior efficacy compared to placebo in inducing clinical remission in patients with moderate to severe ulcerative colitis.

The Indian government has established Standard Operating Procedures (SOPs) for Clinical Research Organizations (CROs) to ensure the safety and quality of clinical trials.

Cardurion Pharmaceuticals has been named one of the Endpoints 11 most promising private biotechnology companies of 2024, recognizing its innovative approach to cardiovascular disease treatment.

The CEPHEUS trial suggests that transplant-ineligible multiple myeloma patients may benefit from quadruplet regimens in the frontline setting, leading to deeper responses and improved progression-free survival.

Oncology nurses play a crucial role in educating patients about potential side effects of trastuzumab deruxtecan (T-DXd), such as nausea, hair loss, and interstitial lung disease.